Caplin Point subsidiary receives USFDA approval for Sodium Nitroprusside injection to reduce BP

The product is a generic therapeutic equivalent version of NITROPRESS (Sodium Nitroprusside) 50 mg/vial of Hospira Worldwide, INC, Caplin said in a filing.

New Delhi: Caplin Steriles Limited, a wholly-owned subsidiary company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for it's Abbreviated New Drug Application (ANDA) Sodium Nitroprusside injection, 50 mg/2 ml (25 mg/ml) Vial.

The product is a generic therapeutic equivalent version of NITROPRESS (Sodium Nitroprusside) 50 mg/vial of Hospira Worldwide, INC.

Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute congestive heart failure.

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Commenting on the approval, C.C.Paarthipan, Chairman of Caplin Point Laboratories Limited said, "This is the third ANDA approval under Caplin Steriles name and we hope to have a couple more in the next few months, which should help us close the year strongly."

"Added to this, our entry into captive API manufacturing for several of our ANDAs should augment our control over Compliance, Cost and Continuity in supply, " Paarthipan added.

According to IQVIA {IMS Health), Sodium Nitroprusside had US sales data of approximately $8 million for the 12-months period ending March 2019.

Caplin Steriles Ltd. has developed and filed 13 ANDAs on its own and with partners, with 6 approvals so far.

The Company is also working on a portfolio of 35 simple and complex Injectable and Ophthalmic products, to be filed over the next 4 years.

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